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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
August 04, 2022
Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.
August 03, 2022
The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.
This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
August 02, 2022
Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.
Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.
July 20, 2022
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
July 15, 2022
Exhibitors display innovations for parenteral and solid dose products.
July 02, 2022
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.